Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

Status: Recruiting
Phase: Phase 3
Diagnosis: Pediatric Leukemia
NCT ID: NCT00703820 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-337

 

The purpose of this study is to assess the feasibility and efficacy of a novel form of therapy—haploidentical NK cell transplantation—in patients with standard-risk AML. In addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted therapy and further improvements in supportive care.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Barbara Degar, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Age less than or equal to 21 years at time of study entry. - No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or less ) for hyperleukocytosis. - Written informed consent according to institutional guidelines - Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment - Male and female participants must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Exclusion Criteria: - Down syndrome - Acute Promyelocytic Leukemia (APL) - Juvenile Myelomonocytic Leukemia (JMML) - Fanconi anemia (FA) - Kostmann syndrome - Shwachman syndrome - Other bone marrow failure syndromes - Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol. - Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of IT therapy, hydroxyurea, or low-dose cytarabine as stated above. The patient must have recovered from all acute toxicities from any previous therapy. - Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). - Pregnant or lactating patients. - Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
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